Baclofen

Product NDC
72162-2374
11-digit product format
721622374
Labeler code
72162
Product ID
72162-2374_e5ef89a6-e033-4da0-87a0-a895bfeadf66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212378
Marketing category
ANDA
Marketing start
2024-06-15
Substance
BACLOFEN
Active strength
20 mg/1
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197392

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2374-0Baclofen1000 in 1 BOTTLETABLET1000101
72162-2374-1Baclofen100 in 1 BOTTLETABLET100101
72162-2374-2Baclofen120 in 1 BOTTLETABLET120101
72162-2374-6Baclofen60 in 1 BOTTLETABLET60101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2374-0EA - Each72162-23740dd13406-bc6b-4fbc-8c9f-b50fa0453b4212024-08-12
72162-2374-1EA - Each72162-2374af584e52-ee15-4e41-87e0-01727c80b66712024-08-12
72162-2374-2EA - Each72162-2374ae4cbfd1-bcf6-4298-9506-66f57e999de912024-08-12
72162-2374-6EA - Each72162-2374e477808e-6cc4-46f4-a9bd-2e527a8e412412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2374BACLOFEN TABLET [BRYANT RANCH PREPACK]101Current NDC, 4 package rows20240905_655db2a3-daf7-4f4b-8f64-4a6d81fdc165.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN655db2a3-daf7-4f4b-8f64-4a6d81fdc165101
197392baclofen 20 MG Oral TabletSCD655db2a3-daf7-4f4b-8f64-4a6d81fdc165101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2374-0721622374001000 TABLET in 1 BOTTLE (72162-2374-0) 1000 tablet2024-07-18NoNoHistorical
72162-2374-172162237401100 TABLET in 1 BOTTLE (72162-2374-1) 100 tablet2024-07-18NoNoHistorical
72162-2374-272162237402120 TABLET in 1 BOTTLE (72162-2374-2) 120 tablet2024-07-18NoNoHistorical
72162-2374-67216223740660 TABLET in 1 BOTTLE (72162-2374-6) 60 tablet2024-07-18NoNoHistorical